BioCentury
ARTICLE | Politics & Policy

SCOTUS decision a boon to biopharmas in failure-to-warn cases

May 21, 2019 10:05 PM UTC

A U.S. Supreme Court decision that remands Merck v. Albrecht back to the Court of Appeals for the Third Circuit for a judge to make a final ruling will help drug companies avoid unpredictable jury decisions in failure-to-warn suits.

The case centers around the question of whether FDA’s denial of a proposal from Merck & Co. Inc. (NYSE:MRK) to add a warning about the risk of stress fractures to the label of osteoporosis drug Fosamax alendronate precluded the company from warning the public about a different risk, atypical femoral fractures. Merck had claimed federal preemption to avoid liability in state court for failing to warn patients about the risk of atypical fractures (see "Supreme Court May Reset FDA-State Power Balance")...



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